Transmuscular Quadratus Lumborum Block on Post-Operative Analgesia After Total Hip Arthroplasty

NCT ID: NCT05465967

Last Updated: 2022-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2022-09-01

Brief Summary

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The aim of this study is to compare between the post-operative analgesic effect of two approaches of transmuscular quadratus lumborum block (transverse versus paraspinous sagittal transmuscular QLB) in total hip replacement surgery.

Detailed Description

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During the preanesthetic assessment, all patients will be educated about the visual analogue scale (VAS) for pain assessment, with scores ranging from 0 to 10 (0 represent no pain, while10 represent maximum intolerable pain).

The patients will be randomly classified into three equal groups (25 patients each). Group allocation will be done by computer generated random numbers and closed opaque sealed envelopes. The study will be designed to be double blind as all patients and postoperative assessor will be blinded to group assignment.

Patients will be randomized to one of three equal groups:

* Group I: Control group (n= 25 patients): Patients in this group will receive ipsilateral sham ultrasound-guided block via subcutaneous injection of 1 ml of normal saline after surgery.
* Group II (n= 25 patients): Patients in this group will receive an ipsilateral single shot of transverse transmuscular approach of QLB (30 ml of plain bupivacaine 0.25%) after surgery using ultrasonographic guidance.
* Group III (n= 25 patients): patients in this group will receive an ipsilateral single-shot of paraspinous sagittal approach of QLB (30 ml of plain bupivacaine 0.25%) after surgery using ultrasonographic guidance.

Conditions

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Quadratus Lumborum Block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group I: Control Group

Patients in this group will receive ipsilateral sham ultrasound-guided block via subcutaneous injection of 1 ml of normal saline after surgery.

Group Type SHAM_COMPARATOR

Quadratus lumborum Block

Intervention Type PROCEDURE

1-Transverse transmuscular Quadratus lumborum block: ultrasound transducer will placed transverse to the abdominal flank to visualise abdominal muscle layers. moving the probe posteriorly, the transverse process of the lumbar vertebra, Quadratus lumborum, Psoas Major and erector spinae muscles identified as a 'Shamrock sign'. the needle will inserted through the back muscles to fascial plane between the Quadratus lumborum and Psoas Major, local anesthetic will injected .2- paraspinous sagittal Quadratus lumborum block: ultrasound transducer will be directed caudally in a sagittal plane lateral to the spinous process of L4. moving laterally until the Quadratus lumborum is evident in its long axis with a characteristic sonographic image of three muscle layers appearing from posterior to anterior as: erector spinae, Quadratus lumborum, and Psoas major muscle the needle will be advanced through the muscles, until it pierces the Quadratus lumborum. local anesthetic will be injected.

Group II:( transverse trans muscular Quadratus lumborum group).

patients in this group will receive an ipsilateral single-shot of paraspinous sagittal approach of Quadratus lumborum BLOCK(30 ml of plain bupivacaine 0.25%) after surgery using ultrasonographic guidance.

Group Type ACTIVE_COMPARATOR

Quadratus lumborum Block

Intervention Type PROCEDURE

1-Transverse transmuscular Quadratus lumborum block: ultrasound transducer will placed transverse to the abdominal flank to visualise abdominal muscle layers. moving the probe posteriorly, the transverse process of the lumbar vertebra, Quadratus lumborum, Psoas Major and erector spinae muscles identified as a 'Shamrock sign'. the needle will inserted through the back muscles to fascial plane between the Quadratus lumborum and Psoas Major, local anesthetic will injected .2- paraspinous sagittal Quadratus lumborum block: ultrasound transducer will be directed caudally in a sagittal plane lateral to the spinous process of L4. moving laterally until the Quadratus lumborum is evident in its long axis with a characteristic sonographic image of three muscle layers appearing from posterior to anterior as: erector spinae, Quadratus lumborum, and Psoas major muscle the needle will be advanced through the muscles, until it pierces the Quadratus lumborum. local anesthetic will be injected.

Group III : paraspinous sagittal approach of Quadratus lumborum BLOCK

patients in this group will receive an ipsilateral single-shot of paraspinous sagittal approach of Quadratus lumborum BLOCK (30 ml of plain bupivacaine 0.25%) after surgery using ultrasonographic guidance.

Group Type ACTIVE_COMPARATOR

Quadratus lumborum Block

Intervention Type PROCEDURE

1-Transverse transmuscular Quadratus lumborum block: ultrasound transducer will placed transverse to the abdominal flank to visualise abdominal muscle layers. moving the probe posteriorly, the transverse process of the lumbar vertebra, Quadratus lumborum, Psoas Major and erector spinae muscles identified as a 'Shamrock sign'. the needle will inserted through the back muscles to fascial plane between the Quadratus lumborum and Psoas Major, local anesthetic will injected .2- paraspinous sagittal Quadratus lumborum block: ultrasound transducer will be directed caudally in a sagittal plane lateral to the spinous process of L4. moving laterally until the Quadratus lumborum is evident in its long axis with a characteristic sonographic image of three muscle layers appearing from posterior to anterior as: erector spinae, Quadratus lumborum, and Psoas major muscle the needle will be advanced through the muscles, until it pierces the Quadratus lumborum. local anesthetic will be injected.

Interventions

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Quadratus lumborum Block

1-Transverse transmuscular Quadratus lumborum block: ultrasound transducer will placed transverse to the abdominal flank to visualise abdominal muscle layers. moving the probe posteriorly, the transverse process of the lumbar vertebra, Quadratus lumborum, Psoas Major and erector spinae muscles identified as a 'Shamrock sign'. the needle will inserted through the back muscles to fascial plane between the Quadratus lumborum and Psoas Major, local anesthetic will injected .2- paraspinous sagittal Quadratus lumborum block: ultrasound transducer will be directed caudally in a sagittal plane lateral to the spinous process of L4. moving laterally until the Quadratus lumborum is evident in its long axis with a characteristic sonographic image of three muscle layers appearing from posterior to anterior as: erector spinae, Quadratus lumborum, and Psoas major muscle the needle will be advanced through the muscles, until it pierces the Quadratus lumborum. local anesthetic will be injected.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 75 patients, aged between 21- 80 years old, of both sex American society of Anesthesiology I - III scheduled for total hip replacement surgery.

Exclusion Criteria

* Patient refusal.
* Coagulopathy
* Spinal deformities
* Peripheral neuropathy; sensory disorders in the leg requiring surgery and chronic pain.
* Mental dysfunction, psychiatric illnesses and cognitive dysfunction.
* History of drug abuse \&chronic analgesic use
Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Mai Abdelhaleem Kamal Nida

assistant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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YASSER M RAGHEB, PROF

Role: STUDY_CHAIR

TANYAU

Locations

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Tanata university hospital

Tanta, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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mai A nida, msc

Role: CONTACT

+201012328193

Mohammed Sh Elbrol, MD

Role: CONTACT

+201063345623

References

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Singh JA, Lewallen D. Predictors of pain and use of pain medications following primary Total Hip Arthroplasty (THA): 5,707 THAs at 2-years and 3,289 THAs at 5-years. BMC Musculoskelet Disord. 2010 May 13;11:90. doi: 10.1186/1471-2474-11-90.

Reference Type BACKGROUND
PMID: 20462458 (View on PubMed)

Abduallah MA, Ahmed SA, Abdelghany MS. The effect of post-operative ultrasound-guided transmuscular quadratus lumborum block on post-operative analgesia after hip arthroplasty in elderly patients: A randomised controlled double-blind study. Indian J Anaesth. 2020 Oct;64(10):887-893. doi: 10.4103/ija.IJA_275_20. Epub 2020 Oct 1.

Reference Type BACKGROUND
PMID: 33437078 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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QL block on hip arthroplasty

Identifier Type: -

Identifier Source: org_study_id

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